Test di un protocollo TMS accelerato per il disturbo da uso di metanfetamine
The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- University of Colorado Anschutz Medical Campus
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 21-65 years inclusive;
- Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
- By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
- Provides a urine drug screen positive for methamphetamine;
- Able to provide informed consent;
- No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
- Adequate English proficiency for study consent, and completion of the study instruments.
Exclusion Criteria:
- Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
- Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
- Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
- Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;
- Presence of a clinically significant abnormality on baseline MRI;
- Inability to have an MRI;
- Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);
- Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
- History of head injury with loss of consciousness for more than 15 minutes;
- Diagnosis of dementia;
- Prescribed benzodiazepines or anticonvulsants;
- Currently enrolled in formal substance use disorder treatment;
- Metal implants or non-removable metal objects above the waist;
- Lifetime history of prior clinical treatment with TMS;
- Serious risk of suicide or homicide;
- Unable/unwilling to follow the study procedures;
- History of intractable migraine;
- Assessed to be at risk for alcohol or opioid withdrawal.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Sham TMS
Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks. |
The TMS Cool-B65 A/P coil on its placebo side delivers electrical stimulation to the scalp (e.g., mimicking sensations associated with real stimulation) but does not provide magnetic stimulation to the targeted cortical structure. |
|
Sperimentale: Active TMS
Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks. |
The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tolerability
Lasso di tempo: 5 days
|
Proportion completing at least 20 TMS session - sham vs. active |
5 days
|
|
Study emergent adverse events
Lasso di tempo: 12 weeks
|
Incidence of study emergent adverse events - sham vs. active |
12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Weeks of continuous abstinence
Lasso di tempo: 12 weeks
|
Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen. |
12 weeks
|
|
Days of methamphetamine use
Lasso di tempo: 12 weeks
|
Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview. |
12 weeks
|
|
Time to first methamphetamine use
Lasso di tempo: 12 weeks
|
Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen |
12 weeks
|
|
Methamphetamine craving
Lasso di tempo: 12 weeks
|
Craving as measured on the Stimulant Craving Questionnaire-Brief - sham vs. active. Each item is scored 0-6 (from Strongly Disagree=0 to Strongly Agree=6) with items #4 and #7 reverse scored. The investigators will average all 10 items as the total score, with higher scores indicating greater levels of craving. |
12 weeks
|
|
Methamphetamine craving on visual analog scale
Lasso di tempo: 12 weeks
|
Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving. |
12 weeks
|
|
MRI cue craving
Lasso di tempo: Pre- and Post- TMS stimulation in week 1
|
Cue craving data will be collected pre- and post-TMS stimulation in week 1 |
Pre- and Post- TMS stimulation in week 1
|
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MRI resting state
Lasso di tempo: Pre- and Post- TMS stimulation in week 1
|
Resting state data will be collected pre- and post-TMS stimulation in week 1 |
Pre- and Post- TMS stimulation in week 1
|
Collaboratori e investigatori
Sponsor
Collaboratori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 23-1044
- K24DA058882 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
No plan to share IPD.
Informazioni su farmaci e dispositivi, documenti di studio
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